News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children aged three years and older who are at high risk for tooth decay.

Learn more about FDA’s Postmarketing Requirements and Commitments Searchable Database.

The drug, which Lilly in-licensed four years ago and is designed to inhibit a protein known as P2X7, did not meet the company’s "high internal bar for success," a spokesperson said.

Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.

Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone.

Otsuka Pharmaceuticals could shell out over $400 million in total for the Asia-Pacific rights to 4D-150, which combines a VEGF-C inhibitory RNAi with Regeneron’s Eylea into a single ocular injection.

Before being discontinued, the P2X7 receptor blocker had cleared a master protocol study in chronic pain, though Eli Lilly said that results were not sufficient for advancement of the Asahi Kasei–partnered asset.

Drugs that will be subject to rebates in 340B next year include Bristol Myers Squibb’s Eliquis, Johnson & Johnson’s Stelara and Novo Nordisk’s Novolog.

Gilead is actively looking for late-stage and de-risked assets for potential deals across various therapeutic spaces, including liver disease, cancer and immunology.

With the shutdown ongoing, Evommune plans to close its IPO on Nov. 5 via a Securities Act clause that allows registrations to come into effect after a certain window has passed.

New safety information for healthcare professionals  Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecallyPRAC agreed on a direct…, Agenda Agenda of the PRAC meeting 27 – 30 October 2025Draft…, PRAC statistics: November 2025 , PRAC statistics: November 2025 English (EN) (104.68 KB – PDF)First…, Ongoing referrals ProcedureLevamisole-containing medicinal products, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Ensho Therapeutics CEO Neena Bitritto-Garg, recently named to BioSpace’s 40 Under 40, proved her mettle managing one of the toughest partnerships out there: the one between Eisai and Biogen that led to new Alzheimer’s drugs Aduhelm and Leqembi.

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

Alnylam and Neurocrine shares tumbled despite upbeat sales reports. Elsewhere, Biogen is dealing with what one analyst called “lackluster” appeal and Bristol Myers’ prized schizophrenia drug again underwhelmed.

CEO David Ricks wants Eli Lilly’s upcoming obesity pill to be accessible to patients who need it, but the company still needs to pay for the next generation of obesity medicines to come after that.

Content: Announcement: Distribution of the reserve list for antimicrobial drugs via the Canadian Clinical Drug Data Set; Safety Brief: Change in the colour from teal to red for the ferrule / cap of marketed cisatracurium besylate injectable products; Notice of authorization with conditions: Amtagvi

While the company’s sales outlook was otherwise rosy, Merck took sales hits on Gardisil, Proquad, Varivax and Vaxneuvance.

Many of the most devastating illnesses are like black boxes to science. Most cancer deaths, for example, are caused by strain from the disease spreading throughout the body, fueled by the few tumor cells able to survive the travel to different body parts and form new growths. But biologists know relatively little about how these aggressive cells function, which hinders knowledge of cancer progression and resistance.

Oncology isn’t the only field in pursuit of valuable information about single rare cells—fields including developmental biology, immunology, stem cell biology, neuroscience, and infectious disease all require studying individual cells. By looking at cells one at a time rather than in bulk, researchers can uncover their genetic makeup and unique behavior, observing subtle but influential traits that would be otherwise hidden.

The key to breakthroughs in all of these fields, experts say, is clear: better single-cell sequencing technology.

To study rare cells, researchers need to separate individual cells from big clumps of human tissue, but doing so threatens the viability of the very cells they hope to analyze. Existing technologies to isolate cells often do so by sawing small pieces off of a larger tissue chunk with a scalpel or razor, potentially damaging the cells so they can no longer be studied properly. Other methods use enzymes to isolate cells, but those procedures are time consuming and can threaten useful cell characteristics. “And for rare cell types, every little loss counts,” says Katalin Susztak, who studies chronic kidney disease at the University of Pennsylvania.

Hypersonic Levitation in Cell Isolation

A new method of isolating and suspending cells, called hypersonic levitation and spinning (HLS), relies on acoustic resonators and micro-electromechanical systems (MEMS) technology to yield biology breakthroughs. The group from Tianjin University in China responsible for its development found that the tool is able to isolate more cells in substantially less time than traditional techniques.

HLS uses a metal probe to transmit billions of vibrations per second into a water mixture surrounding human cancer tissue in a research lab. The resulting “liquid jets” peel a single cancer cell away from thousands of others in the chunk of tissue, an entirely contact-free process. The cell is held in place by the liquid jets—suspended in the fluid but free to spin at any degree—allowing for complete visual analysis from every angle with advanced microscopy.

Xuexin Duan, who leads the Tianjin University group, and his colleagues set out to invent a tool that would not only lessen the threat to cells during the isolation process, but speed the whole process up. They started by considering the fact that living cells are generally surrounded by water. “We asked: could we use a finely tuned physical field within the fluid itself to act as a gentle, invisible hand?” Duan says.

They came up with a small, high-frequency ultrasound probe that uses three MEMS-based resonators to vibrate tissue in a water and enzyme solution. When the device is turned on, a signal generated at 2.49 gigahertz alerts a printed circuit board to send out a high-frequency voltage. Once the voltage reaches the MEMS resonators, an inverse piezoelectric effect is triggered, yielding billions of vibrations per second that generate acoustic waves in the surrounding fluid.

A reflector beneath each resonator bounces the waves in a specific pattern, causing the water-enzyme mixture to start flowing and spinning quickly—creating liquid jets powerful enough to remove a single cell from a clump of tissue, but gentle enough to do so without deterioration. Once a cell is isolated, the same acoustic mechanisms allow it to float and spin freely in the fluid.

While much of the design is unique, HLS is more of a refinement than a completely new device. “This levitation method has been used before for other types of work,” says Z. Hugh Fan, a biomedical MEMS and microfluidics researcher at the University of Florida. He says that HLS “is an improvement, not a dramatic change.” Still, Fan thinks the tool shows serious potential.

The Tianjin University researchers tested their device on human renal cancer tissue samples. Using HLS, the group was able to isolate 90 percent of cells in 15 minutes, but could only do the same for 70 percent of cells in an hour using conventional methods. HLS performed so well because it helps the enzymes penetrate the tissue and break up cells “without the need for harsh mechanical grinding or prolonged enzymatic exposure,” Duan says.

Concerns Over HLS in Single-Cell Research

The biggest concern from University of Pennsylvania’s Susztak is that HLS may pose a threat to cells sensitive to high-frequencies. “Even slight perturbations matter in single-cell work,” she says. “Will the acoustic fields perturb the cell’s biochemistry?”

Duan is confident that his team’s design is safe for fragile cells because they experience a controlled force, not the raw acoustic wave, he claims. “This intense force field is confined to the fluid, not the cell directly.”

Outside experts have more concerns about implementation. Susztak notes that “biological labs are unforgiving” so research tools must be reliable and robust, and MEMS devices in fluid tend to face drift and calibration issues. Cost and ease of access concern Fan, though he thinks that both issues could be solved by business efforts. “How mainstream it will become is really dependent on commercialization,” he says.

For these reasons and others, Duan says that his team has spun HLS into a startup company—Convergency Biotech—with the goal to develop HLS workstations user-friendly enough for any lab. And he’s optimistic about the enterprise. “We believe MEMS-based acoustic tools will become a mainstream component of the biological toolkit,” he says.

Single-cell researchers show similar optimism, but in the company of caution. Susztak considers HLS “a clever tool with genuine promise,” she says, “but it must prove itself in the messy world of real biology.”

drug recalls page, FDA’s role

Bristol Myers Squibb beat analyst and consensus estimates for the third quarter with $12.2 billion in sales, but executives on the company’s investor call faced questions about a sluggish uptake for schizophrenia drug Cobenfy as well as a highly anticipated Alzheimer’s psychosis readout for the product.

The investment, which will expand Eli Lilly’s existing campus in Puerto Rico, is slated to create 100 new jobs, on top of around 1,000 construction-related roles.

With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help developers bring them to market more quickly and cheaply. 

Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, HHS leaders said while announcing new draft guidance.

A soft gel filled with tiny bubbles might not look like much. But when pulsed with ultrasound waves, the material behaves like natural muscle: contracting, gripping, and lifting with surprising strength.

The discovery, reported this week in Nature, introduces a new kind of artificial muscle—one powered not by wires, batteries, or pumps, but by sound.

The acoustic trick behind these “bubble muscles” opens the door to wireless control, quick responsiveness, and even deep-tissue operation. That could lead to soft robots that wriggle through tight spaces with lifelike agility, surgical tools that bend and flex inside the body, or gentle grippers that can manipulate fragile objects without breaking them.

“From a medical perspective, it’s really cool,” says Ryan Truby, a materials scientist at Northwestern University who was not involved in the research. “They’re using relatively simple approaches, but they’re integrating them in clever new ways.”

Challenges in Artificial Muscle Design

The robotics community has long struggled to design artificial muscles that rival the flexibility and suppleness of living tissue. Motors and hydraulics can deliver force but lack finesse and may pose safety risks inside the body, while soft actuators—driven by heat, air, or chemical reactions—tend to be bulky, inefficient, or too slow for practical use.

Daniel Ahmed, a nanoroboticist at ETH Zürich, took a different approach. Harnessing the power of acoustic resonance, he and his colleagues embedded thousands of microscopic bubbles into a soft, biocompatible gel, arranging the air sacs in lattice-like patterns so they leap into motion when struck by ultrasound.

Different bubble sizes respond to different ultrasound frequencies, allowing control over which parts of the material bend.ETH Zürich/Nature

Adjusting both the ultrasound frequency and the size of the bubbles in their muscle-mimicking arrays enabled the researchers to direct the gel to flex, rotate, or deform—in effect, turning invisible vibrations into controllable motion. “By activating different sets of frequencies,” Ahmed says, “you can actually get programmable muscle.”

Bubble Muscles in Soft Robotics

Several prototype devices showcase the bubble muscles in action.

In one demonstration, the researchers fashioned a claw-like gripper that snapped shut around live zebrafish larvae without damaging the delicate animals. In another, they built a stingray-shaped soft robot whose fins, studded with tiny bubbles of three distinct sizes, undulated under ultrasound, propelling it smoothly through water—even within the stomach of a pig. (Not a living one, in case you wondered.)

Making the most of their pig tissue from the local abattoir, Ahmed’s team also showed how the material could grip. On the surface of a pig heart, for example, a patch of the bubble-patterned gel clung tightly and stayed in place for more than an hour while flexing in response to ultrasound.

A bandage-sized patch sticks firmly to the outside of a pig heart.ETH Zürich/Nature

In another experiment, the researchers encased their artificial muscle material in a biodegradable capsule and inserted it into a pig bladder. Once the capsule dissolved, ultrasound activated the device, prompting it to unfurl and latch onto the inner tissue wall—a hint of how such systems might one day be used for targeted treatments inside the body.

“We can actually use our system as patches for delivering drugs,” says study co-author Zhan Shi, a former Ph.D. student in Ahmed’s lab now at Westlake University in Hangzhou, China. “That has really practical applications.”

Ultrasound Imaging in Biomedical Implants

One notable feature of the ultrasound-driven artificial muscle is that the microbubbles involved can be tracked with standard ultrasound imaging. And because the actuation frequencies (between 1 and 100 kilohertz) are far below those used for clinical imaging (between 1 and 20 megahertz), the two functions don’t interfere.

As yet, however, all the proof-of-concept demonstrations have been trialed on dead tissues, and it remains to be seen how well the system performs inside a living rat or pig, much less in a human body—especially as bones and other irregular tissues may scatter and weaken the ultrasound signal, or fluids flowing inside the body might interfere with controlled movement.

“You can’t tell if this is really working or not without in vivo evidence,” says W. Hong Yeo, a bioengineer at Georgia Tech who was not involved in the study. The system is also constrained by the fact that prolonged actuation causes the bubbles to expand, destabilizing their function after around half an hour.

Nonetheless, Yeo points to their tiny scale and rapid responsiveness as features that could make the bubble muscles especially attractive for biomedical implants. “That catches my eye,” he says. “It’s very unique and it makes sense.”

The deal, which enables patients to pick up orders placed through Lilly’s online channel at Walmart pharmacies, is the latest move by the company to expand its direct-to-consumer services. 

Late-breaking Phase III data show ianalumab, Novartis’ dual-targeted antibody, reduced disease activity and patient burden in Sjögren’s disease, the pharma reported at the American College of Rheumatology Convergence congress on Wednesday.

This page lists Biosimilars Guidance documents.

Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.

Already sky high after the success of its limb-girdle muscular dystrophy therapy, reported on Monday, BridgeBio’s shares rose nearly 8% more as encaleret balanced calcium levels in patients with a genetic thyroid disorder.